Duns Number:054318779
Device Description: Gel Refills for PM311 Heat Pain Pro (T.E.N.S.)
Catalog Number
PMGEL
Brand Name
Omron Gel Refills for PM311
Version/Model Number
PMGEL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160115,K160115,K160115
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
a5f8f9b0-8a1c-4161-b775-668ad59939a1
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
May 17, 2017
Package DI Number
10073796637528
Quantity per Package
4
Contains DI Package
00073796637521
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |